Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

A Study to Learn About the Study Medicine Called Berobenatide (PF-08653944) in People With Overweight or Obesity

3. september 2026 opdateret af: Pfizer

A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF ONCE-MONTHLY PF-08653944 IN ADULTS WITH OVERWEIGHT OR OBESITY (VESPER-6)

The purpose of this clinical study is to learn about the effects and safety of berobenatide (PF-08653944). This may help people with overweight or obesity lose weight. People in this study may also have type 2 diabetes.

About 950 adults will be in this study. Berobenatide will be compared to a placebo. A placebo does not have any medicine in it but looks just like the medicine being studied. Berobenatide or placebo is given by a shot under the skin in the belly area. The objective of the study is to compare the experiences of people receiving berobenatide to those of the people who do not to assess if the study medicine is effective and safe.

People will take part in this study for about 20 months. During this time, they will have about 15 study visits at the site. They will also have 2 study visits over the phone.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

954

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Brasilien
      • São Paulo, Brasilien, 04266-010
        • Ikke rekrutterer endnu
        • CEPIC - Centro Paulista de Investigação Clínica
    • São Paulo
      • Campinas, São Paulo, Brasilien, 13060-080
        • Ikke rekrutterer endnu
        • Saraiva & Berlinger Ltda EPP Instituto de Pesquisa Clínica de Campinas
      • São José do Rio Preto, São Paulo, Brasilien, 15090-000
        • Ikke rekrutterer endnu
        • Fundação Faculdade Regional de Medicina de São José do Rio Preto
  • Canada
    • British Columbia
      • Surrey, British Columbia, Canada, V3Z2N6
        • Rekruttering
        • Ocean West Research Clinic
    • New Brunswick
      • Moncton, New Brunswick, Canada, E1G 1A7
        • Rekruttering
        • GA Research Associates Ltd.
    • Ontario
      • Hamilton, Ontario, Canada, L8L 5G8
        • Rekruttering
        • The Wharton Medical Clinic Clinical Trials Inc
      • Hamilton, Ontario, Canada, L8J 0B6
        • Rekruttering
        • Winterberry Research Inc.
      • Toronto, Ontario, Canada, M3J 0K2
        • Rekruttering
        • Canadian Phase Onward Inc.
  • Forenede Stater
    • California
      • Canoga Park, California, Forenede Stater, 91304
        • Rekruttering
        • San Fernando Valley Health Institute
      • Escondido, California, Forenede Stater, 92025
        • Rekruttering
        • Headlands Research California, LLC
      • Modesto, California, Forenede Stater, 95350
        • Rekruttering
        • ImmuniMet, LLC
      • Sacramento, California, Forenede Stater, 95821
        • Rekruttering
        • Clinical Trials Research
      • Tustin, California, Forenede Stater, 92780
        • Rekruttering
        • University Clinical Investigators, Inc.
      • Walnut Creek, California, Forenede Stater, 94598
        • Rekruttering
        • Diablo Clinical Research, Inc.
      • West Hills, California, Forenede Stater, 91307
        • Rekruttering
        • Southern California Retina Specialists
    • Florida
      • Crystal River, Florida, Forenede Stater, 34429
        • Rekruttering
        • Nature Coast Clinical Research
      • Lecanto, Florida, Forenede Stater, 34461
        • Rekruttering
        • West Coast Eye Institute
      • Miramar, Florida, Forenede Stater, 33027
        • Rekruttering
        • South Broward Research
      • New Port Richey, Florida, Forenede Stater, 34652
        • Rekruttering
        • Suncoast Clinical Research, Inc.
      • New Port Richey, Florida, Forenede Stater, 34652
        • Rekruttering
        • West Coast Medical Associates
      • Pembroke Pines, Florida, Forenede Stater, 33024
        • Rekruttering
        • Center for Diabetes, Obesity and Metabolism Inc
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60611
        • Ikke rekrutterer endnu
        • Northwestern University
      • Chicago, Illinois, Forenede Stater, 60607
        • Rekruttering
        • Cedar Crosse Research Center
      • Evanston, Illinois, Forenede Stater, 60201
        • Rekruttering
        • Endeavor Health - Family Medicine Administration
      • Skokie, Illinois, Forenede Stater, 60077
        • Rekruttering
        • Endeavor Health- Endocrinology Research
    • Indiana
      • Evansville, Indiana, Forenede Stater, 47714
        • Rekruttering
        • MediSphere Medical Research Center, LLC
    • Kentucky
      • Louisville, Kentucky, Forenede Stater, 40213
        • Rekruttering
        • Monroe Biomedical Research
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21229
        • Ikke rekrutterer endnu
        • Ascension Saint Agnes Heart Care
    • Michigan
      • Flint, Michigan, Forenede Stater, 48504
        • Rekruttering
        • Aa Mrc Llc
    • Nebraska
      • Omaha, Nebraska, Forenede Stater, 68198
        • Rekruttering
        • University of Nebraska Medical Center
    • New Mexico
      • Albuquerque, New Mexico, Forenede Stater, 87102
        • Rekruttering
        • Albuquerque Clinical Trials, Inc.
    • New York
      • New York, New York, Forenede Stater, 10021
        • Rekruttering
        • Weill Cornell Medicine - Comprehensive Weight Control Center
      • Rochester, New York, Forenede Stater, 14609
        • Rekruttering
        • Rochester Clinical Research, LLC
    • North Carolina
      • Greensboro, North Carolina, Forenede Stater, 27405
        • Rekruttering
        • Medication Management LLC
      • Wilmington, North Carolina, Forenede Stater, 28401
        • Rekruttering
        • Accellacare - Wilmington
      • Wilmington, North Carolina, Forenede Stater, 28401
        • Rekruttering
        • Jeffrey Coleman, OD
    • Ohio
      • Cincinnati, Ohio, Forenede Stater, 45202
        • Rekruttering
        • Midwest Eye Center
      • Cincinnati, Ohio, Forenede Stater, 45219
        • Rekruttering
        • Velocity Clinical Research, Mt. Auburn
    • Texas
      • Houston, Texas, Forenede Stater, 77079
        • Rekruttering
        • PlanIt Research, LLC (Monitoring Room)
      • Houston, Texas, Forenede Stater, 77079
        • Rekruttering
        • PlanIt Research, LLC
      • San Antonio, Texas, Forenede Stater, 78230
        • Rekruttering
        • VIP Trials
    • Virginia
      • Norfolk, Virginia, Forenede Stater, 23504
        • Rekruttering
        • York Clinical Research, LLC
  • Japan
    • Osaka
      • Suita, Osaka, Japan, 565-0853
        • Rekruttering
        • Medical Corporation Heishinkai OCROM Clinic
    • Tokyo
      • Chuo-ku, Tokyo, Japan, 104-0031
        • Rekruttering
        • Fukuwa Clinic
      • Chuo-ku, Tokyo, Japan, 103-0027
        • Rekruttering
        • Tokyo-Eki Center-building Clinic
      • Chuo-ku, Tokyo, Japan, 103-0027
        • Rekruttering
        • Tokyo Center Clinic
      • Shinjuku-ku, Tokyo, Japan, 160-0008
        • Rekruttering
        • Medical Corporation Heishinkai ToCROM Clinic
  • Sydkorea
    • Daejeon
      • Daejeon, Daejeon, Sydkorea, 35365
        • Ikke rekrutterer endnu
        • Konyang University Hospital
    • Gyeongsangnam-do
      • Yangsan, Gyeongsangnam-do, Sydkorea, 50612
        • Ikke rekrutterer endnu
        • Pusan National University Yangsan Hospital
    • Incheon-gwangyeoksi
      • Incheon, Incheon-gwangyeoksi, Sydkorea, 21565
        • Ikke rekrutterer endnu
        • Gachon University Gil Medical Center

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • Aged ≥18 years.
  • BMI of: ≥30 kg/m2 or ≥27.0 kg/m2 to <30.0 kg/m2 and must have at least 1 of the following weight-related co-morbidities: hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease, or T2D.

Exclusion Criteria:

  • Have a self-reported body weight change greater than 5% within 90 days prior to Screening.
  • Diagnosis of type 1 diabetes or any other form of diabetes other than T2D.
  • History of acute or chronic pancreatitis.
  • Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN-2).

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Behandlingsgruppe 1
Deltagerne vil modtage PF-08653944 ved subkutan injektion.
Medicin: PF-08653944
Ved subkutan injektion
Eksperimentel: Behandlingsarm 2
Deltagerne vil modtage PF-08653944 ved subkutan injektion.
Medicin: PF-08653944
Ved subkutan injektion
Eksperimentel: Behandlingsarm 3
Deltagerne vil modtage PF-08653944 ved subkutan injektion.
Medicin: PF-08653944
Ved subkutan injektion
Placebo komparator: Placebo
Deltagerne vil modtage matchende placebo ved subkutan injektion.
Andet: Placebo
Ved subkutan injektion
Eksperimentel: Treatment Arm 4
Participants will receive PF-08653944 by Subcutaneous Injection.
Medicin: PF-08653944
Ved subkutan injektion

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Percent change from baseline in body weight
Tidsramme: Baseline, Week 72
Baseline, Week 72

Sekundære resultatmål

Resultatmål
Tidsramme
Skift fra baseline i Hba1c
Tidsramme: Baseline, uge ​​72
Baseline, uge ​​72
Change from baseline in body weight
Tidsramme: Baseline, Week 72
Baseline, Week 72
Change from baseline in waist circumference
Tidsramme: Baseline, Week 72
Baseline, Week 72
Percentage of Participants achieving ≥5% of body weight reduction from baseline
Tidsramme: Baseline, Week 72
Baseline, Week 72
Percentage of Participants achieving ≥10% of body weight reduction from baseline
Tidsramme: Baseline, Week 72
Baseline, Week 72
Percentage of Participants achieving ≥15% of body weight reduction from baseline
Tidsramme: Baseline, Week 72
Baseline, Week 72
Percentage of Participants achieving ≥20% of body weight reduction from baseline
Tidsramme: Baseline, Week 72
Baseline, Week 72
Percent change from baseline in body weight in participants with type 2 diabetes
Tidsramme: Baseline, Week 72
Baseline, Week 72
Change from baseline in Systolic Blood Pressure (SBP)
Tidsramme: Baseline, Week 72
Baseline, Week 72
Change from baseline in Impact of Weight on Quality of Life-Lite-Clinical Trial (IWQoL-Lite-CT) Physical Function composite score
Tidsramme: Baseline, Week 72
Baseline, Week 72
Percentage of Participants achieving ≥25% of body weight reduction from baseline
Tidsramme: Baseline, Week 72
Baseline, Week 72
Change from baseline in Diastolic Blood Pressure (DBP)
Tidsramme: Baseline, Week 72
Baseline, Week 72
Change from Baseline in Fasting Glucose
Tidsramme: Basline, Week 72
Basline, Week 72
Change from Baseline in Fasting insulin
Tidsramme: Baseline, Week 72
Baseline, Week 72
Change from Baseline in revised Homeostatic Model Assessment insulin sensitivity as a percentage of normal (HOMA2-%S)
Tidsramme: Baseline, Week 72
Baseline, Week 72
Change from Baseline in revised Homeostatic Model Assessment beta-cell function as a percentage of a normal reference population (HOMA2-%B)
Tidsramme: Baseline, Week 72
Baseline, Week 72
Change from baseline in Fasting Total Cholesterol
Tidsramme: Baseline, Week 72
Baseline, Week 72
Change from baseline in Fasting Low-density lipoprotein cholesterol
Tidsramme: Baseline, Week 72
Baseline, Week 72
Change from baseline in Fasting Very low-density lipoprotein cholesterol
Tidsramme: Baseline, Week 72
Baseline, Week 72
Change from baseline in Fasting Non-High-density lipoprotein cholesterol
Tidsramme: Baseline, Week 72
Baseline, Week 72
Change from baseline in Fasting High-density lipoprotein cholesterol
Tidsramme: Baseline, Week 72
Baseline, Week 72
Change from baseline in Fasting triglycerides
Tidsramme: Baseline, Week 72
Baseline, Week 72
Change from baseline in high-sensitivity C-reactive protein
Tidsramme: Baseline, Week 72
Baseline, Week 72
Change from baseline in interleukin-6
Tidsramme: Baseline, Week 72
Baseline, Week 72
Change from baseline in interleukin-1 beta
Tidsramme: Baseline, Week 72
Baseline, Week 72
Change from baseline in IWQoL-Lite-CT total score
Tidsramme: Baseline, Week 72
Baseline, Week 72
Change from baseline in IWQoL-Lite-CT Physical composite score
Tidsramme: Baseline, Week 72
Baseline, Week 72
Change from baseline in IWQoL-Lite-CT Psychosocial composite score
Tidsramme: Baseline, Week 72
Baseline, Week 72
Change from baseline in Short Form 36 health survey (SF-36) domain scales and component summary scales
Tidsramme: Baseline, Week 72
Baseline, Week 72
Change from Baseline in Control of Eating Questionnaire (CoEQ) subscales
Tidsramme: Baseline, Week 72
Baseline, Week 72
Change from Baseline in Food Noise Questionnaire (FNQ) total score
Tidsramme: Baseline, Week 72
Baseline, Week 72
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Tidsramme: Baseline, Week 72
Baseline, Week 72
Number of Participants with Serious adverse events (SAEs)
Tidsramme: Baseline, Week 72
Baseline, Week 72
Number of Participants with adverse avents leading to discontinuation
Tidsramme: Baseline, Week 72
Baseline, Week 72
Number of Participants with Adverse Events of Special Interest (AESIs)
Tidsramme: Baseline, Week 72
Baseline, Week 72
Percentage of Participants with a waist-to-height ratio of <0.53
Tidsramme: Baseline, Week 72
Baseline, Week 72

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Pfizer

Efterforskere

  • Studieleder: Pfizer CT.gov Call Center, Pfizer

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

10. juni 2026

Primær færdiggørelse (Anslået)

4. maj 2028

Studieafslutning (Anslået)

21. juni 2028

Datoer for studieregistrering

Først indsendt

12. maj 2026

Først indsendt, der opfyldte QC-kriterier

12. maj 2026

Først opslået (Faktiske)

19. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

4. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • C6491013
  • VESPER-6 (Anden identifikator: Alias Study Number)
  • 2026-525318-75-00 (Registry Identifier: CTIS (EU))

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner